The Legitimacy of Standardisation as a Regulatory Technique


Book Description

This timely book examines the field of European and global standardisation, showing how standards give rise to a multitude of different legal questions. It explores diverse topics in regulation such as food safety, accounting, telecommunications and medical devices. Each chapter offers in-depth analysis of a number of key policy areas. These multi-disciplinary contributions go beyond the field of law, and provide cross-disciplinary comparisons.




The Interplay of Global Standards and EU Pharmaceutical Regulation


Book Description

This book analyses the implementation of global pharmaceutical impact standards in the European risk regulation framework for pharmaceuticals and questions its legitimacy. Global standards increasingly shape the risk regulation law and policy in the European Union and the area of pharmaceuticals is no exception to this tendency. As this book shows, global pharmaceutical standards set by the International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH), after they are adopted through the European Medicines Agency (EMA), are an important feature of the regulatory framework for pharmaceuticals in the EU. In addition to analysing the influence of these global standards in the EU legal and policy framework, the book questions the legitimacy of the Union's reliance on global standards in terms of core administrative law principles of participation, transparency and independence of expertise. It also critically examines the accountability of the European Commission and the European Medicines Agency as participants in the global standard-setting and main implementation gateway of the global pharmaceutical standards into the European Union.




The Legal Effects of EU Soft Law


Book Description

This incisive book evaluates the legal effects of soft law, its foundations and how they behave in some of the most innovative areas of EU law. Combining theory, language and sectoral insights, this comprehensive review uses case studies to shed new light on the three core areas of soft law.




Transnational Securities Regulation


Book Description

The book provides an analysis of the emergence, evolution, and transformation of transnational securities regulation and of the influences from and the interactions between global regulatory powers in the field. Combining insights from law and political science, the work employs a two-tier complementary "on-the-books" and "in-action” approach. The more classical "on-the-books" approach draws on scholarship in United States and European Union securities regulation; transnational regulation and global administrative law; regime complexity; global governance studies; and the regulatory production of the International Organisation of Securities Commissions (IOSCO). The law in-action approach leverages the author’s experience as Compliance senior professional in a multinational financial institution as well as research interviews with senior IOSCO staff. The author’s findings enable the reader to develop an original understanding of IOSCO, its standards, and its unique place in the transnational regulatory arena. They also challenge the doxa that the US are the only driving regulatory power in the securities area when in fact, other regulatory powers are emerging – for the time being, the EU. The balance has shifted and regulatory compromises are achieved at different points in the rule making process.




Legal Pluralism in European Contract Law


Book Description

This book deals with lawmaking in consumer markets, focusing on the increased importance of contracts and self-regulation which have become primary instruments for designing and monitoring legal relationships between businesses and consumers. It asks how common values and objectives of EU law can be protected when lawmaking shifts beyond state law.




The Evolution of Transnational Rule-Makers through Crises


Book Description

In recent years transnational private regulators have emerged and multiplied. In this book, experts from various academic disciplines offer empirically grounded case studies and theoretical insights into the evolution and resilience of these bodies through crises. Transnational private regulators display considerable flexibility if compared to public institutions both in exercising their rule-making functions and adapting and transforming in light of endogenous or exogenous crises events calling for change. The contributors identify such events and reflect on their impact on transnational private rule-makers. This edited volume covers important areas of global production and finance that are associated with private rule-making and delves into procedural, substantive and practical elements of private rule-making processes. At a policy level, the book provides comparisons among practices of private bodies in various areas, allowing for important lessons to be drawn for all public and private stakeholders active in, or affected by, private and public rule-making. This title is Open Access.





Book Description




Digital Technologies and Public Procurement


Book Description

Bringing together insights from political economy, public policy, science, technology and legal scholarship, this book explores the role of public procurement in digital technology regulation.




The Law and Practice of Global ICT Standardization


Book Description

This book explores how ICT standards, as powerful technical rules that affect society, emerge and are legitimised.




Standardizing the World


Book Description

The EU has pursued many trade pacts across the world. This is part of its foreign policy: as the third largest economy in the world and lacking hard power, the EU relies on trade agreements to project its interests. These are often complex and far-reaching initiatives that have the potential to shape not only economic but also political and social life in the EU and its trading partners. In Standardizing the World, Francesco Duina and Crina Viju-Miljusevic have gathered a group of leading experts to present an unprecedented assessment of the EU's efforts to standardize a wide array of economic, political, and social aspects of life through its trade agreements across the globe. Drawing on economic sociology and constructivist strands in international political economy, the volume examines what is being standardized, the extent to which the EU has been able to project its worldviews, and what explains the observable patterns of standardization across policy areas and geographies. Ten leading scholars from across the world offer as many chapters on EU agreements with all major trading partners and cover efforts in social and labor rights, the environment, investments, rule of law and anti-corruption, agriculture and food quality, services, public procurement, sustainable development, and more. Their findings paint a picture of a dynamic EU capable of projecting its worldviews across the globe that is nonetheless not always consistent or successful. Standardizing the World provides a wide-ranging and rigorous understanding of standardization in trade agreement as well as the EU's abilities to project its power and worldviews across the globe.